ARTFX MEDICAL Cervical PEEK Cages— 510(k) K240893

Substantially Equivalent

Artfx Medical

FDA 510(k) clearance K240893 for ARTFX MEDICAL Cervical PEEK Cages, Substantially Equivalent on 2024-06-28. Applicant: Artfx Medical.

Clearance details

Applicant: Artfx Medical
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2024-04-01
Decision date: 2024-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.